17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS

17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS
17.1 Applicability
17.10 This section applies to any party other than the original manufacturer who may trade and/or take possession, repack, relabel, manipulate, distribute or store an API or intermediate.
17.11 All agents, brokers, traders, distributors, repackers, and relabellers should comply with GMP as defined in this Guide.
17.2 Traceability of Distributed APIs and Intermediates
17.20 Agents, brokers, traders, distributors, repackers, or relabellers should maintain complete traceability of APIs and intermediates that they distribute. Documents that should be retained and available include:
− Identity of original manufacturer
− Address of original manufacturer
− Purchase orders
− Bills of lading (transportation documentation)
− Receipt documents
− Name or designation of API or intermediate
− Manufacturer’s batch number
− Transportation and distribution records
− All authentic Certificates of Analysis, including those of the original manufacturer
− Retest or expiry date
17.3 Quality Management
17.30 Agents, brokers, traders, distributors, repackers, or relabellers should establish, document and implement an effective system of managing quality, as specified in Section 2.
17.4 Repackaging, Relabelling and Holding of APIs and Intermediates
17.40 Repackaging, relabelling and holding of APIs and intermediates should be performed under appropriate GMP controls, as stipulated in this Guide, to avoid mix-ups and loss of API or intermediate identity or purity.
17.41 Repackaging should be conducted under appropriate environmental conditions to avoid contamination and cross-contamination.
17.5 Stability
17.50 Stability studies to justify assigned expiration or retest dates should be conducted if the API or intermediate is repackaged in a different type of container than that used by the API or intermediate manufacturer.
17.6 Transfer of Information
17.60 Agents, brokers, distributors, repackers, or relabellers should transfer all quality or regulatory information received from an API or intermediate manufacturer to the customer, and from the customer to the API or intermediate manufacturer.
17.61 The agent, broker, trader, distributor, repacker, or relabeller who supplies the API or intermediate to the customer should provide the name of the original API or intermediate manufacturer and the batch number(s) supplied.
17.62 The agent should also provide the identity of the original API or intermediate manufacturer to regulatory authorities upon request. The original manufacturer can respond to the regulatory authority directly or through its authorized agents, depending on the legal relationship between the authorized agents and the original API or intermediate manufacturer. (In this context "authorized" refers to authorized by the manufacturer.)
17.63 The specific guidance for Certificates of Analysis included in Section 11.4 should be met.
17.7 Handling of Complaints and Recalls
17.70 Agents, brokers, traders, distributors, repackers, or relabellers should maintain records of complaints and recalls, as specified in Section 15, for all complaints and recalls that come to their attention.
17.71 If the situation warrants, the agents, brokers, traders, distributors, repackers, or relabellers should review the complaint with the original API or intermediate manufacturer in order to determine whether any further action, either with other customers who may have received this API or intermediate or with the regulatory authority, or both, should be initiated. The investigation into the cause for the complaint or recall should be conducted and documented by the appropriate party.
17.72 Where a complaint is referred to the original API or intermediate manufacturer, the record maintained by the agents, brokers, traders, distributors, repackers, or relabellers should include any response received from the original API or intermediate manufacturer (including date and information provided).
17.8 Handling of Returns
17.80 Returns should be handled as specified in Section 14.52. The agents, brokers, traders, distributors, repackers, or relabellers should maintain documentation of returned APIs and intermediates.